a solution that overcomes the challenges of implementing ... · a solution that overcomes the...

Exa™ Mammo A Solution that Overcomes the Challenges of Implementing Digital Breast Tomosynthesis

A W H I T E P A P E R

Konica Minolta Healthcare Americas, Inc.

E X A M A M M O | A W H I T E P A P E R

Konica Minolta Healthcare Americas • konicaminolta.com/medicalusa • October 2017

Numerous published studies have shown that digital breast

tomosynthesis (DBT), also referred to as 3D mammography, can

overcome limitations of traditional 2D mammography, enhance

lesion conspicuity, and improve sensitivity and specificity.1-4

Other studies report that adding 3D mammography or ultra-

sound to regular screening mammograms can detect more

cancers in dense breasts.5,6 In the US, nearly 50% of women in

their 40s have dense breasts.7

A 2014 study reported a 41% increase in the detection of invasive

breast cancers and a 29% increase in the detection of all breast

cancers with DBT compared to 2D mammography.8 Another study

found that the rate of recalls was nearly 37% lower among women

who had DBT compared to women who only had conventional

mammography (2D). The benefits of DBT were further reported in

a 2016 study, including a 50% increase in invasive cancer detec-

tion in women with heterogeneously dense breasts.9

With evidence supporting the clinical benefits of DBT, new guide-

lines from the National Comprehensive Cancer Network (NCCN)

recommending that physicians consider tomosynthesis as an

option for their patients’ annual breast cancer screenings and

three new CPT codes for screening and diagnostic DBT, along with

Centers for Medicare and Medicaid (CMS) reimbursement of DBT

for screening in conjunction with 2D mammography, the market

for DBT is expected to continue growing. By 2018, DBT units will

exceed 2D mammography systems in the US and by 2020 the DBT

market value will reach $521B.

While DBT delivers clinical advantages over 2D mammography,

there are workflow and infrastructure challenges to implementing

the technology. Exa™ Mammo from Konica Minolta Healthcare

Americas is designed to overcome the

challenges associated with viewing, read-

ing and reporting DBT exams.

Implementation challenges One of the most significant impediments

to implementing DBT is the large files size

generated by the modality. On average,

a DBT study (450MB) is approximately

10times the size of a conventional 2D

mammography exam (45MB) and can

sometimes be significantly larger (up

to 3GB).10,11 This large file size places an

INTRODUCTION

Figure 1. Exa Mammo from Konica Minolta Healthcare is designed to overcome the challenges associated with viewing, reading and reporting DBT exams.

immediate strain on the network and IT infrastructure, resulting in

lag time that can directly impact a physician’s reading capabilities,

productivity and potentially the facility’s financial bottom line. As a

result of this large file size for DBT studies, many facilities will need

to invest in upgrading network capabilities and infrastructure.

In mammography/breast imaging, radiologists review the cur-

rent exam and compare it to the patient’s prior exams, which are

typically pre-fetched from a server and downloaded onto the

workstation. The importance of reviewing multiple prior mammo-

grams with the current exam is underscored by a published study

that found a significant decrease in recall rates in a retrospective

analysis of 46,288 consecutive screening mammograms. Mammo-

grams interpreted without comparison to prior mammograms led

to a recall rate of 16.6%. When at least one prior mammogram was

compared to the current mammogram, the recall rate dropped

to 7.8%, while comparison of two or more prior mammograms

further dropped the recall rate to 6.3%.12

However, downloading prior and current studies requires more

local storage and can consume network bandwidth, slowing down

the transfer of the DBT study and other tasks being performed

by radiologists and technologists. If the prior study is not pre-

fetched, it can take several minutes to load, further straining the

network speed and bandwidth.

Radiologists reading remotely will also be impacted by network

bandwidth and speed. Further, not all third-party mammography

viewers have the capability to display DBT images, which may

require installation of a dedicated DBT workstation at the imaging

facility. As a result, facilities are resorting to deploying radiologists

at each remote DBT facility. This conflicts with the main principle

of teleradiology and can dramatically increase labor costs.



Cybersecurity Downloading and pre-fetching patient studies onto a workstation

may introduce additional cybersecurity vulnerabilities. A June

2017 report by the US Department of Health and Human Services,

Health Care Industry Cybersecurity Task Force, warned that US

healthcare cybersecurity is in critical condition, citing a “severe

lack of security talent” in the majority of health delivery organiza-

tions. The report also noted that Meaningful Use requirements

may have led to “hyper-connectivity without secure design and

implementation.”13

Twenty-one cybersecurity experts helped compile the report,

which also found that the healthcare industry experienced more

breaches due to cybersecurity than any other industry.11 An

increase in ransomware has only exacerbated this issue, as is

evident by the recent attack on National Health Service (NHS)

hospitals in the United Kingdom that shut down medical care in

16 hospitals and impacted nearly 40 NHS organizations.14,15

Cost and ROI of DBT The cost of a DBT system can vary from just under $400,000 for a

basic system configuration to just over $550,000 for a fully config-

ured solution that may include computer-aided detection (CAD),

a dedicated workstation, contrast-enhanced spectral mammog-

raphy and upright biopsy equipment. By comparison, the average

cost of a FFDM unit is around $275,000.16

Interest in DBT has fueled an increase in the price of digital mam-

mography systems, which can often be upgraded to DBT. Accord-

ing to the latest public data available from the Modern Healthcare/

ECRI Institute Technology Price Index, digital mammography

(likely with a tomosynthesis option) was one of the top 10 most

expensive capital items reported by ECRI Institute members in

November 2016.17 The index also reported a 4.1% increase in the

cost of digital mammography over a 12-month period (November

2015-November 2016).

In 2015, CMS adopted new CPT coding for DBT when used in

conjunction with screening and diagnostic mammography. Coding

changes for DBT were implemented in 2017 to simplify mammog-

raphy codes that were previously separate for FFDM, film mam-

mography, CAD and DBT.18

For both screening and diagnostic DBT, the Medicare reimburse-

ment component is $30.86 for professional (physician) and $25.48

for technical (facility), or $56.34 for both. An imaging site would

recover its initial investment in a basic system configuration

($400,000) after billing for 2,219 DBT exams or in a fully configured

system ($550,000) after billing for 4,881 DBT exams.

DBT with Exa Mammo Considering the cost of DBT and the volume required to recoup

the initial investment before generating income, facilities may

seek solutions that reduce overall expense yet enable remote

reading without requiring extensive upgrades to networks and

infrastructure.

Exa Mammo is a first-of-its-kind Konica Minolta solution that

preserves an existing investment in imaging and information

technology while enhancing radiologists’ efficiency and

productivity. The platform enables the viewing of images from

any modality, including DBT and digital 2D mammograms, from

any workstation* with instant access and zero lag time.

Two key features make Exa Mammo one of a kind. First, with 100%

Diagnostic Zero Footprint (ZFP) technology, the user/facility

never has to install a viewer. It functions on any operating system

or browser, and it is a true diagnostic viewer for any modality,

including DBT. Second, Server-Side Rendering (SSR) allows

immediate access to even the largest file sizes, such as DBT, as well

as priors. SSR eliminates the need to download images or files,

which can reduce radiology-related network traffic by up to 60%.

Further, SSR significantly increases exam opening speed, as all

rendering and processing occurs on the server, not the workstation,

and removes the need to pre-fetch or plan ahead with routing rules.

For cybersecurity, Exa minimizes unwanted exposure to patient

data with no data transferred to or stored on workstations.

By implementing Exa Mammo, facilities can avoid the additional

expense and maintenance of a separate mammography

workstation. It works as a stand-alone solution or supplements an

existing PACS or VNA and enables radiologists to read remotely

from any location. Exa Mammo also offers a customizable

“EXA MAMMO IS A FIRST-OF-ITS-KIND KONICA MINOLTA SOLUTION THAT PRESERVES

AN EXISTING INVESTMENT IN IMAGING AND INFORMATION TECHNOLOGY WHILE ENHANCING RADIOLOGISTS’ EFFICIENCY

AND PRODUCTIVITY.”



mammography workflow engine and

optional voice recognition and report-

creation technologies.

With SSR and ZFP, Exa Mammo is

exceedingly simple to deploy and use

on existing workstations. It integrates

with other interfaces and saves facilities

from expensive IT upgrades when

deploying DBT, while enhancing security

of patient data by never downloading

images or information onto an individual

workstation. For all required (MQSA)

mammography tracking and reporting,

Exa Mammo integrates with third-party

software, such as Penrad, MRS and

Ikonopedia. Through this software,

tracking items such as Bi-Rads assessment

and recommendations, breast density,

calcification and geometry selection, and

biopsy protocol selection are all presented

to the radiologist during reading and

dictation. Each third-party software

meets MQSA standards put forth by the

American College of Radiology.

Conclusion DBT is an evolution in digital

mammography systems, with initial

clinical evidence indicating a higher

cancer detection rate, particularly in

women with dense breasts, and a lower

false-positive recall rate. However, the

large file size of DBT exams presents

implementation challenges and can

place a strain on existing networks and IT

infrastructure. The equipment’s high cost

can further impede a facility’s economic

ability to provide this potentially life-

saving technology to patients.

Exa Mammo from Konica Minolta can

help overcome these limitations with

a cost-effective solution that does not

require any image downloads, dedicated

tomosynthesis workstation or expensive

Figure 2. Exa Mammo is a true multi-modality breast imaging workstation that can be used for reviewing MRI exams in addition to mammography, DBT and ultrasound.

Figure 3. Exa Mammo integrates with third-party software to help track items such as Bi-Rads assessment and recommendations, breast density, calcification and geometry selection, and biopsy protocol selection.

Figure 4. With Server Side Rendering and Diagnostic Zero Footprint technologies, Exa Mammo is exceedingly simple to deploy and use on existing workstations.


IT upgrades. It delivers fast access to images and prior studies

with zero lag time, minimizes unwanted exposure to patient data,

and can be deployed on existing workstations. With ZFP and SSR

technologies, facilities can embrace remote reading/teleradiology

for a more cost-effective and productive workflow.

With Exa Mammo, breast imaging facilities have a cost-effective

and efficient workflow solution for DBT.

*For digital mammography, a 5MP monitor is required per MQSA guidelines.

References

1. Skaane P, Gullien R, Bjorndal H, et al. Digital breast tomosynthesis (DBT): initial experience in a clinical setting. Acta Radiol. 2012;53:524–9. [PubMed]

2. Rafferty EA, Park JM, Philpotts LE, et al. Assessing radiologist performance using combined digital mammography and breast tomosynthesis compared with digital mammography alone: results of a multicenter, multireader trial. Radiology. 2013;266(1):104–13. [PMC free article] [PubMed]

3. Skaane P, Bandos AI, Gullien R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013;267:47–56.[PubMed]

4. Michell MJ, Iqbal A, Wasan RK, et al. A comparison of the accuracy of film-screen mammography, full-field digital mammography, and digital breast tomosynthesis. Clin Radiol. 2012;67:976–81. [PubMed]

5. Tagliafico AS, Calabrese M, Mariscotti G, et al. Ad Adjunct Screening With Tomosynthesis or Ultrasound in Women With Mammography-Negative Dense Breasts: Interim Report of a Prospective Comparative Trial. J Clin Oncol, June 2016; 34:1882-1888.

6. Skaane P, Osteras BH, Eben EB, Gullien R. Comparison of Digital Mammography (FFDM) and FFDM Plus Digital Breast Tomosynthesis in Mammography Screening for Cancer Detection According to Breast Parenchyma Density. Scientific paper, RSNA 2014. VSBR31-16. Available at: https://press.rsna.org/timssnet/rsna/media/pr2014/skaane/abstract/SkaaneAbstract.pdf.

7. DenseBreast-info, Inc. Available at: http://densebreast-info.org/information-for-dense-breast-patients.aspx.

8. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.

9. Rafferty EA, Durand MA, Conant EF, et al. Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26;315(16):1784-6.

10. Trachtman L. PACS Requirements for Digital Breast Tomosynthesis (DBT), 3D Mammography, & Molecular Breast Imaging (MBI). Available at: http://blog.purview.net/pacs-requirements-for-digital-breast-tomosynthesis.

11. DICOM Library. Available at: https://www.dicomlibrary.com/dicom/study-structure/

12. Hayward JH, Ray KM, Wisner DJ, et al. Improving Screening Mammography Outcomes Through Comparison With Multiple Prior Mammograms. Am J Roentgenol, 2016; 207: 918-924.

13. Health Care Industry Cybersecurity Task Force. Report on Improving Cybersecurity in the Health Care Industry, June 2017. Available at: https://www.phe.gov/Preparedness/planning/CyberTF/Documents/report2017.pdf.

14. CNN. Link: http://www.cnn.com/2017/05/12/health/uk-nhs-cyber-attack/index.html.

15. BBC. Link: http://www.bbc.com/news/health-39899646

16. Bennett R. Purchasing Insight: Digital Mammography. MD Buyline. Available at: https://www.mdbuyline.com/research-library/articles/pricing-for-digital-breast-tomosynthesis/

17. Technology Price Index. Modern Healthcare, 2017. Available at: http://www.modernhealthcare.com/section/technology-price-index.

18. American College of Radiology. Information on Coding, Value and Coverage for Breast Tomosynthesis. Available at: https://www.acr.org/Advocacy/eNews/Archive/2014/20141114-Issue/Information-on-Coding-Value-and-Coverage-for-Tomosynthesis.

“DBT IS AN EVOLUTION IN DIGITAL MAMMOGRAPHY SYSTEMS, WITH INITIAL

CLINICAL EVIDENCE INDICATING A HIGHER CANCER DETECTION RATE, PARTICULARLY IN

WOMEN WITH DENSE BREASTS, AND A LOWER FALSE-POSITIVE RECALL RATE.”

Konica Minolta Healthcare Americas, Inc. 411 Newark Pompton Turnpike Wayne, New Jersey 07470

Tel: (973) 633-1500 Fax: (973) 523-7408 konicaminolta.com/medicalusa

M1206 1017 RevA

Exa 3D Mammo Technical White Paper 10/2017

© 2017 Konica Minolta Healthcare Americas, Inc.